Health-related quality of life (HRQoL), functioning, and symptoms with odronextamab monotherapy in patients (pts) with relapsed or refractory follicular lymphoma (R/R FL) by POD24 status in the ELM-2 study.

• DOI: 10.1200/jco.2024.42.16_suppl.e19057
• Publication Date: 2024-06-10T18:41:03Z
• Authors: Jose Caetano Vill...; Laura Magnano Mayer; Benoît Tessoulin; Seok-Goo Cho; Michal Taszner; Silvana Novelli; Stefano Luminari; Michele Merli; Ana Jiménez Ubieto; Michelle Poon; David Tucker; Jan Andrzej Walewski; Cristina Ivanescu; Aafia Chaudhry; Hesham Mohamed; Srikanth R. Ambati; James Harnett; Siddhesh Kamat; Tae Min Kim
• Keywords: Follicular lymphoma; Refractory (planetary science)

e19057 Background: In ELM-2 (NCT03888105), a Ph 2, single arm, open label trial, odronextamab demonstrated robust efficacy, generally manageable safety, and overall maintenance of patient-reported outcomes (PROs) in R/R FL pts (Villasboas et al. ASH 2023). FL, with disease progression within 2 yrs frontline chemoimmunotherapy (POD24) are hard to treat poor clinical outcomes, representing an unmet need. We report PROs by POD24 status Grade 1–3a from ELM-2. Methods: Pts received IV 21-day cycles (C): 80 mg QW C1–4, C1 dose step up mitigate cytokine release syndrome, then 160 Q2W (Q4W if complete response ≥9 mo) until progression. were collected at baseline (BL), Wks 2–4, 10, Q8W Yr 1, Q12W 2. Post-hoc subgroup analyses performed on six EORTC QLQ-C30 scales, the EQ-5D-3L VAS, FACT-Lym LymS. Estimated mean change BL (CFB) was analyzed using mixed models for repeated measures (MMRM) through Wk 42 (≥10 last assessment). Published meaningful CFB thresholds used define deterioration/improvement responder analyses. Results: By Jan 31, 2023, 140 had odronextamab. (n=70) younger than without (n=70; median age 57.5 vs 62.0 y), fewer prior Tx lines (median 3), higher proportion double refractory anti-CD20 Ab + alkylator (53% 29%). Objective rate similar evaluable (n=63; 79%) (n=65; 80%) POD24. PRO questionnaire completion ranged 52–95% across groups. Descriptive suggest scores status, showing good HRQoL/functioning low symptom burden, maintained minimal between-group differences (overlapping 95% CIs LS [Table]). both groups, more reported or improvement deterioration visits, except fatigue 10 Conclusions: heavily pretreated HRQoL, functioning, symptoms irrespective status. Clinical trial information: NCT03888105 . [Table: see text]